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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LIFECODES Class II IDv2 for use with Luminex - 10888234400301

LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex

SilverStat Calcium Alginate Pad with Pure Metallic Silver - 00811331010220

Sterile 2" x 2" calcium alginate pad with pure metallic silver - TZ Medical Inc.
ARGENTUM MEDICAL, LLC
8870-07
In Commercial Distribution

  • 00811331010220 ()


  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Silverlon Antimicrobial Wound Dressing - 00857278000467

IV/Catheter Dressing 5/8 in Lifesavers with 1.5mm access
ARGENTUM MEDICAL, LLC
IVCD-MINI
In Commercial Distribution

  • 10857278000464 ()
  • 00857278000467 ()


  • Vascular catheterization support/maintenance kit, non-medicated

Simpurity - 00856253007187

Silver PU Foam with Silicone 2 x 2 inches (Each)
SAFE N' SIMPLE LLC
SNS74422
In Commercial Distribution

  • 00856253007187 ()

  • Height: 2 Inch
  • Length: 2 Inch
SNS74422

  • Wound-nonadherent dressing, absorbent, antimicrobial

Simpurity - 00856253007217

Silver PU Foam with Silicone 7 x 7 inches (Each)
SAFE N' SIMPLE LLC
SNS74477
In Commercial Distribution

  • 00856253007217 ()

  • Length: 7 Inch
  • Height: 7 Inch
SNS74477

  • Wound-nonadherent dressing, absorbent, antimicrobial

Simpurity - 00856253007200

Silver PU Foam with Silicone 6 x 6 inches (Each)
SAFE N' SIMPLE LLC
SNS74466
In Commercial Distribution

  • 00856253007200 ()

  • Height: 6 Inch
  • Length: 6 Inch
SNS74466

  • Wound-nonadherent dressing, absorbent, antimicrobial

Simpurity - 00856253007194

Silver PU Foam with Silicone 4 x 5 inches (Each)
SAFE N' SIMPLE LLC
SNS74445
In Commercial Distribution

  • 00856253007194 ()

  • Length: 5 Inch
  • Height: 4 Inch
SNS74445

  • Wound-nonadherent dressing, absorbent, antimicrobial

Neptune ® Pressure Disc with Calcium Alginate Wound Dressing - 10811331010197

Neptune ® Round Pressure Disc with Calcium Alginate Wound Dressing
Tz Medical, Inc.
8880-08
In Commercial Distribution

  • 00811331010190 ()
  • 10811331010197 ()


  • Wound compression dressing

PermaLife - 10816203022995

PermaLife Cell Culture Bag, 325ml, "L" Set with 10cm sheath
ORIGEN BIOMEDICAL, INC.
PL325L
Not in Commercial Distribution

  • 10816203022995 ()


  • Blood/tissue storage/culture container

Ultraxx - 00827002476585

Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G47658
In Commercial Distribution

  • 00827002476585 ()
UNBS-10-15-CS-01

  • Nephrostomy catheter
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